Package leaflet: information for the patient

Acatar Zatoki
200 mg + 30 mg, film-coated tablets
(Ibuprofen + Pseudoephedrine hydrochloride)
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Acatar Zatoki is and what it is used for
Important information before taking Acatar Zatoki
How to take Acatar Zatoki
Possible side effects
How to store Acatar Zatoki
Contents of the pack and other information

1. What Acatar Zatoki is and what it is used for

Acatar Zatoki is a medicine intended for short-term use to relieve symptoms of
influenza and common cold such as: pain and nasal sinus congestion, runny nose, headache, fever,
and musculoskeletal pain.

2. Important information before using Acatar Zatoki

When not to use Acatar Zatoki:

if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (NSAIDs),
in patients who have previously experienced allergic reactions such as rhinitis, urticaria or bronchial asthma after taking acetylsalicylic acid or other NSAIDs,
in patients with active or past peptic ulcer or (and) duodenal ulcer, perforation or bleeding, including those occurring after use of NSAIDs,
in patients with severe liver failure or severe heart failure,
in patients concurrently taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of adverse effects),
during pregnancy and breastfeeding,
in patients with bleeding disorders,
in patients with severe cardiovascular disorders, tachycardia, angina pectoris,
in patients with very high blood pressure (severe hypertension) or arterial hypertension that cannot be controlled with medication,
in patients with severe acute (sudden) or chronic (long-term) kidney disease or renal failure,
in patients with hyperthyroidism,
in patients with diabetes,
in patients with closed-angle glaucoma,
in patients with benign prostatic hyperplasia,
in patients with pheochromocytoma.

Warnings and precautions
Before starting treatment with Acatar Zatoki, discuss this with your doctor or pharmacist.
Special caution is required when using this medicine:

if the patient has systemic lupus erythematosus or mixed connective tissue disease,
if allergic reactions occurred after taking acetylsalicylic acid,
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
if the patient has hypertension and (or) heart function disorders,
if the patient has kidney function disorders,
if the patient has liver function disorders,
if the patient has blood coagulation disorders,
if the patient has active or past bronchial asthma or history of allergic reactions; bronchospasm may occur after taking the medicine,
if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac drugs, corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or may occur in patients who have previously experienced such warning symptoms. If gastrointestinal bleeding or ulceration occurs, the medicine must be discontinued immediately.
Patients with a history of gastrointestinal disorders, particularly elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of therapy.
Concurrent, long-term use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Use of the medicine in dehydrated patients (children and adolescents) increases the risk of kidney function disorders.
Use of anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Allergic reactions to ibuprofen, including respiratory disturbances, facial and neck swelling (angioedema), and chest pain, have been reported.
If these symptoms occur, discontinue Acatar Zatoki immediately and consult a doctor or go to the emergency department.
Before using Acatar Zatoki, the patient should discuss treatment with a doctor or pharmacist if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA);
the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or is a smoker;
the patient has an infection - see below, section titled "Infections".

Do not use higher doses or longer treatment duration than recommended.
If symptoms persist, worsen or do not resolve within 3 days, or if new symptoms appear, contact a doctor.
Skin reactions
Severe skin reactions associated with the use of Acatar Zatoki have been reported.
If any skin rash, mucosal lesions, blisters or other signs of allergy appear, discontinue Acatar Zatoki immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction.
See section 4.
Infections
Acatar Zatoki may mask symptoms of infection such as fever and pain. Therefore, Acatar Zatoki may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is taken during an existing infection and infection symptoms persist or worsen, consult a doctor immediately.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and disappears after discontinuation of therapy. In case of difficulty becoming pregnant, consult a doctor before taking ibuprofen.
This medicine should be used with caution in patients taking tricyclic antidepressants and other sympathomimetic drugs (vasoconstricting agents acting on mucosal blood vessels), appetite suppressants, amphetamine-like drugs, and psychotropic drugs.
If the patient develops fever with generalized skin erythema and vesicular rash, discontinue Acatar Zatoki and contact a doctor or seek immediate medical help. See section 4.
During treatment with Acatar Zatoki, sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis) may occur. If such gastrointestinal symptoms appear, discontinue Acatar Zatoki and seek medical advice or help immediately. See section 4.
During treatment with Acatar Zatoki, reduced blood flow in the optic nerve may occur. In case of sudden vision loss, discontinue Acatar Zatoki and contact a doctor or seek immediate medical help. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of medicines containing pseudoephedrine.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms suggestive of PRES or RCVS occur, discontinue Acatar Zatoki immediately and seek immediate medical help (symptoms, see section 4 "Possible side effects").
Consult a doctor, even if the above warnings refer to conditions occurring in the past.
Children
This medicine is not indicated for children under 12 years of age.
Acatar Zatoki and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Do not take Acatar Zatoki simultaneously with other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other painkillers or acetylsalicylic acid (at analgesic doses). Concurrent use of Acatar Zatoki with these medicines increases the risk of adverse effects.
Acatar Zatoki may affect the action of other medicines or other medicines may affect the action of Acatar Zatoki, for example:

anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan);
diuretics;
corticosteroids (e.g. prednisolone or dexamethasone);
methotrexate (anticancer medicine);
lithium (antidepressant medicine);
zidovudine (antiviral medicine);
MAO inhibitors (e.g. selegiline), including within 14 days after stopping their use;
dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide;
vasoconstricting dopaminergic medicines - dihydroergotamine, ergotamine, methylergonovine;
linezolid;
quinidine;
tricyclic antidepressants;
sympathomimetic nasal decongestants and appetite suppressants;
amphetamine-type sympathomimetic drugs.

Other medicines may also interact with or be affected by treatment with Acatar Zatoki.
Therefore, always consult a doctor or pharmacist before using Acatar Zatoki with other medicines.
Pregnancy, breastfeeding and effects on fertility
During pregnancy, breastfeeding, or if there is suspicion that a woman is pregnant or plans to become pregnant, consult a doctor before using this medicine.
Do not use this medicine during pregnancy or breastfeeding.
Effect of the medicinal product on fertility - see section Warnings and precautions.
Driving and operating machinery
Exercise caution when driving or operating machinery during treatment with this medicine.
Acatar Zatoki contains sucrose and sunset yellow FCF (E110)
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
The medicine contains biologically active excipients. The presence of sunset yellow FCF (E110) may cause allergic reactions.
The medicine contains 0.005 mg of sodium benzoate (E 211) per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Acatar Zatoki

Adults and children over 12 years of age: for immediate relief, 1 to 2 tablets orally every 4 hours
after meals. The lowest effective dose for the shortest necessary duration should be used to
alleviate symptoms. If symptoms of infection (such as fever and pain) persist or worsen,
medical advice must be sought immediately (see section 2). Do not exceed 6 tablets per day.
This medicine should not be given to children under 12 years of age.
Elderly patients: dosage adjustment is not required unless renal or hepatic function is impaired.
Do not exceed the recommended dose.
If the effect of the medicine seems too strong or too weak, consult a doctor.
This medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur,
consult a doctor.
Do not take this medicine for more than 3 days without consulting a doctor.
Taking more Acatar Zatoki than recommended
If a patient has taken more than the recommended dose of Acatar Zatoki, or if a child
accidentally ingests the medicine, always contact a doctor or go to the nearest hospital
to assess potential health risks and receive advice on necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus,
disorientation, and nystagmus. After a large overdose, drowsiness, chest pain, palpitations,
loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine,
feeling cold, and breathing difficulties may occur. Significant increase in heart rate and
elevated blood pressure may also occur.
If more than 1 hour has not passed since the overdose, induce vomiting or perform gastric lavage
or administer activated charcoal. Based on numerous studies on overdose symptoms of pseudoephedrine
contained in combination preparations used for colds and allergies, gastric lavage is recommended
if the ingested amount exceeds 3–4 times the maximum daily dose (i.e., 720–960 mg).
Missing a dose of Acatar Zatoki
Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone experiences them.
You must immediately stop taking Acatar Zatoki and seek immediate medical help if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

sudden, severe headache,
nausea,
vomiting,
confusion,
seizures,
visual disturbances.

Adverse effects occurring not frequently (in 1 to 10 out of 1,000 patients taking the medicine):

headache, dyspepsia, abdominal pain, nausea, urticaria, itching.

Adverse effects occurring rarely (in 1 to 10 out of 10,000 patients taking the medicine):

diarrhoea, flatulence, constipation, vomiting, gastric mucosal inflammation, dizziness, insomnia, restlessness, irritability, and fatigue;
oedema due to kidney and urinary tract disorders.

Adverse effects occurring very rarely (less frequently than in 1 out of 10,000 patients taking the medicine):

black tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
peptic ulcer of the stomach and/or duodenum, gastrointestinal bleeding and perforation, sometimes with fatal outcome, particularly in elderly patients;
in isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis;
reduced urine output, oedema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention);
liver function disorders, particularly during long-term use;
blood morphology abnormalities (anaemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, pancytopenia - haematological disorder involving deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, influenza-like symptoms, fatigue, haemorrhagic rash (e.g. bruises, petechiae, purpura, nosebleeds);
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, dyspnoea, tachycardia - cardiac arrhythmia, hypotension - sudden drop in blood pressure, shock; worsening of asthma and bronchospasm;
in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.

Adverse effects with unknown frequency of occurrence (frequency cannot be estimated from available data):

chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome,
severe disorders affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS),
red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Acatar Zatoki immediately and seek medical help without delay. See also section 2,
skin becomes sensitive to light.

Treatment with NSAIDs has been associated with reports of oedema, hypertension, and heart failure.
Taking medicines such as Acatar Zatoki may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, and increased eosinophil count (a type of white blood cell).
Due to the presence of pseudoephedrine in the medicine, the following adverse effects may occur:
dyspepsia, gastrointestinal disturbances, flushing and skin rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, cardiac arrhythmia, restlessness, insomnia, rarely uncontrolled urination, muscle weakness, tremors, anxiety, hallucinations, thrombocytopenia.
Unknown frequency: ischaemic colitis (inflammation of the large intestine due to inadequate blood supply); sudden fever, skin redness, or multiple small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Acatar Zatoki. See section 2; reduced blood flow in the optic nerve (ischaemic optic neuropathy).
If such symptoms occur, stop taking Acatar Zatoki immediately and contact a doctor or seek immediate medical help.
When used occasionally, adverse effects occur rarely.
In elderly patients, the risk of adverse effects associated with ibuprofen use is increased compared to younger patients. The frequency and severity of adverse effects can be minimized by using the lowest therapeutic dose for the shortest possible duration.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including all possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Acatar Zatoki

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and immediate packaging
(month/year). The labelling on the blister reads: EXP - expiry date,
Lot - batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Acatar Zatoki contains

The active substances in this medicinal product are ibuprofen and pseudoephedrine hydrochloride. One coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
Other excipients: powdered cellulose (Elcema P-100), powdered cellulose (Elcema F-150), maize starch, pregelatinized starch, guar gum, talc, sodium croscarmellose, crospovidone, colloidal anhydrous silica, hardened vegetable oil. Coating: hydroxypropylcellulose, macrogol 400, talc, gelatin, sucrose, kaolin, confectionery sugar (a mixture of sucrose and maize starch), calcium carbonate, Opaglos Clear GS-2-0750 (a mixture of carnauba wax, white wax and methanol-denatured ethanol), dried arabic gum dispersion, maize starch, Opalux Brown AS-16518 (a mixture of sucrose, titanium dioxide (E171), sunset yellow lake (E110), Allura red AC lake (E129), indigo carmine lake (E132), povidone, sodium benzoate (E211)).

What Acatar Zatoki looks like and contents of the pack
Coated tablet for oral use, packed in a blister or in a bottle with a cardboard box.
Available pack sizes
6 tablets – 1 blister of 6 tablets;
12 tablets – 1 blister of 12 tablets;
24 tablets – 2 blisters of 12 tablets;
24 tablets in a bottle.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.,
Ziębicka 40,
50-507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
tel.: +48 (22) 543 60 00